Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the use of electronic medical device equipment manuals by servicers. Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the [...]

By |2021-11-02T12:15:49+00:00November 2nd, 2021|Government, Governments, Healthcare, Legal Advice, Reform, Regulatory|0 Comments

FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]

FDA Remanufacturing Guidance Comment Period Extended

On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|0 Comments

Brexit agreement begins now: Are you ready?

By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on  the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K.  voted to leave the EU.  In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]

By |2021-01-06T03:54:31+00:00January 6th, 2021|Business, Government, Healthcare|0 Comments

FDA adverse event reporting form to include question as to third-party service

By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]

By |2020-10-02T12:49:18+00:00October 2nd, 2020|Government, Healthcare|0 Comments

First federal ‘right to repair’ legislation filed in US to help hospitals through pandemic

An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]

By |2020-08-10T16:14:06+00:00August 10th, 2020|Government, Healthcare|1 Comment

HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at:  In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]

By |2020-05-14T16:45:54+00:00May 14th, 2020|Government, Healthcare|0 Comments


With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is  part of IAMERS’ efforts to reduce the fear-mongering and  to get out the message of independent servicers for safe patient oriented [...]

By |2018-06-08T12:21:42+00:00June 8th, 2018|Government, Healthcare|0 Comments

Congress delays medical device tax for two years

WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due.   The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent [...]

By |2018-01-25T10:18:12+00:00January 25th, 2018|Business, Government|0 Comments
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